WithdrawnNot Applicable

Evidence-Based Osteopathy for Tension-Type Headache (EBOTTH)

Stopped: Problems for satellite centers in obtaining ethical clearance.

0Started 2016-01

Plain-language summary

Tension-type headache (TTH) is a very common primary headache disorder, with important costs for both patients and society. Often these patients are not willing to take prophylactic medications and resort to complementary therapies. Osteopathic manipulative treatment (OMT) is an interesting option in such field, since it is characterized by a low profile of side effects. In this study the investigators will assess the efficacy of OMT (semi-structured evaluation and "black box" treatment) in frequent Episodic TTH (ETTH) in an outpatient setting. Preliminary data for power calculation are already available (Rolle et al. 2014), and the investigators plan to recruit 264 ETHH patients by a multicentric, randomized, double-blind, sham-controlled design.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * age ≥18 and ≤65 years-old, * diagnosis of frequent episodic tension-type headache according to the International Headache Society guidelines, * frequency of attacks ≥3/month, * willing to adhere to study procedures, * signed informed consent Exclusion Criteria: * age \<18 or \>65 years-old, * headache duration less than one year, * history of: major psychiatric disorders, relevant cognitive deficits, chronic pain other than headache, secondary headaches, * any type of headache prophylactic treatment ongoing or started during the study, * hormonal therapy started or modified during the study, * participating to other clinical trials, * not willing to sign informed consent

What they're measuring

Headache frequency

Timeframe: 4 months

Trial details

NCT IDNCT02592850

SponsorUniversity of Milano Bicocca

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-06